A PET scan study of TAK-041; version 1

• Research type

  Research Study

• Full title

  A Phase 1, Open-Label, Randomized, Positron Emission Tomography Study in Healthy Subjects to Determine the Effect of TAK-041 on Amphetamine-Induced Dopamine Release in the CNS After Single-Dose Oral Administration (HMR code: 16-019).

• IRAS ID

  212573

• Contact name

  Jeremy Dennison

• Contact email

  jdennison@hmrlondon.com

• Sponsor organisation

  Takeda Development Centre Europe Ltd

• Eudract number

  2016-002346-23

• Clinicaltrials.gov Identifier

  NCT02959892

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  TAK-041 is an experimental new treatment for schizophrenia, a common and serious mental illness. We’re not sure what causes schizophrenia, but it’s linked to chemical imbalances in the brain. We hope that the study medicine will correct the imbalance by targeting a substance called G protein coupled receptor 139 (GPR139), and that by doing so, it will reduce the amount of another substance in the brain, called dopamine. We hope that the study medicine will work better and have fewer side effects than existing medicines. \n\nWe’re doing this study in up to 12 healthy men, aged 20–55 years. We’ll give participants a single dose of TAK-041 and 2 single doses of a medicine called amphetamine, which increases the amount of dopamine in the brain. We’ll measure whether TAK-041 can stop amphetamine doing that, using PET (positron emission tomography) scans, which make images of the brain. We’ll also assess blood levels and side effects of TAK-041. \n\nParticipants will take up to about 7½ weeks to finish the study. They’ll have up to 3 PET scans and 1 MRI (magnetic resonance imaging) scan. They’ll come to the ward on 5 occasions: for 2 screening visits, 2 study sessions and 1 follow-up visit. They’ll stay on the ward for 5 nights in total. We’ll telephone participants about 1 week after their last visit. \n\nBefore each PET scan, we’ll give participants an injection of radioactive tracer containing carbon-11; the tracer binds to dopamine receptors in the brain, and the PET scan shows where the tracer is. Participants will be exposed to radiation similar to 1½ years’ background radiation. \n\nA pharmaceutical company, Takeda Development Centre Europe Ltd, is funding the study.\nThe study will take place at 1 research unit and 1 imaging centre in London.\n

• REC name

  London - Brent Research Ethics Committee

• REC reference

  16/LO/1493

• Date of REC Opinion

  30 Sep 2016

• REC opinion

  Further Information Favourable Opinion